The following data is part of a premarket notification filed by Siemens Hearing Instruments, Inc. with the FDA for Behind-the-ear Hearing Aid Model 408 W-h.
| Device ID | K891251 |
| 510k Number | K891251 |
| Device Name: | BEHIND-THE-EAR HEARING AID MODEL 408 W-H |
| Classification | Hearing Aid, Air Conduction |
| Applicant | SIEMENS HEARING INSTRUMENTS, INC. 10 CORPORATE PLACE SOUTH CORPORATE PARK 287 Piscataway, NJ 08854 |
| Contact | L Branderbit |
| Correspondent | L Branderbit SIEMENS HEARING INSTRUMENTS, INC. 10 CORPORATE PLACE SOUTH CORPORATE PARK 287 Piscataway, NJ 08854 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-08 |
| Decision Date | 1989-03-31 |